Inguinal Hernia Study Using Biodesign IHM
Inguinal Hernia Study: A Double Blinded Randomized Prospective Study
2 other identifiers
interventional
100
1 country
1
Brief Summary
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2006
CompletedFirst Posted
Study publicly available on registry
October 30, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
August 25, 2015
CompletedNovember 20, 2015
October 1, 2015
7.3 years
October 26, 2006
July 29, 2015
October 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With Inguinal Hernia Recurrence
1 year
Study Arms (2)
1
EXPERIMENTALBiodesign IHM Graft placement
2
ACTIVE COMPARATORPolypropylene mesh placement
Interventions
Biodesign IHM is placed to reinforce the hernia repair
Eligibility Criteria
You may qualify if:
- years of age
- Diagnosis of Unilateral inguinal hernia repair
- Able to provide written consent
You may not qualify if:
- Incarcerated hernia
- Allergic or religious beliefs that disallow porcine material
- Previous hernia repair on the designated hernia site
- Class IV or V anesthesia requirements
- Bowel obstruction
- Peritonitis
- Life expectancy \< 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cook Group Incorporatedlead
- Cook Biotech Incorporatedcollaborator
- MED Institute, Incorporatedcollaborator
Study Sites (1)
University of Maryland
Baltimore, Maryland, 21201, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jason Hodde, Clinical Affairs Manager
- Organization
- Cook Biotech Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy Timmons, M.D.
University of Maryland
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2006
First Posted
October 30, 2006
Study Start
March 1, 2007
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
November 20, 2015
Results First Posted
August 25, 2015
Record last verified: 2015-10